Prismaflex Sets
Brand(s)
Last updated
Summary
Product
Prismaflex Sets
Issue
Medical devices - Labelling and packaging
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
| Affected products | Lot or serial number | Model or catalog number |
|---|---|---|
| Prismaflex Hf20 Set | All lots. | PRISMAFLEX HF20 SET |
| Prismaflex Hf1000 Set | All lots. | PRISMAFLEX HF1000 |
| Prismaflex St60 Set, Prismaflex St100 Set, Prismaflex St150 Set | All lots. | PRISMAFLEX ST150 SET PRISMAFLEX ST100 SET PRISMAFLEX ST60 SET |
Issue
Baxter Corporation is issuing an urgent medical device correction for the Prismaflex sets listed. The current Prismaflex set IFU is a single booklet containing 27 translated languages, and the following products include a mistranslation in the Estonian (EESTI) IFU. The mistranslation indicates contradictory information related to the patient body weight restrictions.
Recall start date: September 15, 2022
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Gastroenterology and urology
Companies
Gambro Industries
7 Avenue Lionel-Terray, Meyzieu, France, 69883
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-64581
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